LIGHTBEAM-U01

A Study of Patritumab Deruxtecan in Children With Relapsed or Refractory Solid Tumors (LIGHTBEAM-U01)

Agent: Patritumab deruxtecan (HER3-DXd; MK-1022)
Phase I/II
Status Recruiting
Sponsor Merck Sharp & Dohme LLC

 

For further information please also consult https://clinicaltrials.gov/study/NCT06941272.

LIGHTBEAM-U01 is a phase 1/2 study of patritumab deruxtecan (HER3-DXd) in children and adolescents with rhabdomyosarcoma or hepatoblastoma that has returned after treatment or has not responded to treatment. The study is investigating the safety of the medicine, the dose to use in children, and whether it can help shrink tumors.

Patritumab deruxtecan is an antibody–drug conjugate (ADC). It combines an antibody that recognizes a protein called HER3 with an anticancer medicine. The aim is to deliver the medicine to cancer cells. It is still an investigational treatment for these childhood cancers.

WHO is the trial for?
  • Children and adolescents aged 1 month to 17 years with confirmed advanced or metastatic rhabdomyosarcoma (RMS) or hepatoblastoma.
  • The cancer has progressed after at least one previous systemic treatment, and no satisfactory standard treatment option is available.
  • Participants must meet further health and recovery requirements.

    Important exclusions include a history of interstitial lung disease (inflammation or scarring of the lungs), certain serious lung or heart conditions, and active infections.

WHAT is the key question that this trial is attempting to answer?

 Is patritumab deruxtecan safe and tolerable for children with relapsed or refractory rhabdomyosarcoma or hepatoblastoma?

What dose should be used, and can it make tumors shrink or disappear?

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcomas and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

 This study is open for recruitment.

WHERE is the trial available?

 This trial is currently conducted in the US, Australia, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey, and in the United Kingdom.

Please check the registry for the latest participating hospitals and their recruitment status.

Central study contact:
Phone: +1 888-577-8839 (toll free)
Email: Trialsites@msd.com

STUDY DESIGN: What does the study look like?

 Phase 1/2 study in two parts:

  • Part 1 (safety lead-in): A smaller group receives patritumab deruxtecan so researchers can assess side effects and identify a suitable dose for children.
  • Part 2: More participants receive the study treatment so researchers can better understand whether it works and continue monitoring safety.

All participants receive the investigational medicine; no placebo group is described.

HOW do I get more information?

 Patient organisations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving sarcoma patients.

If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.org

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

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